- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001129
A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly
Adherence Strategies Using a Medication Manager and an Electronic Medication Reminder System for HIV-Infected Patients Receiving HAART
The purpose of this study is to look at different ways to help patients follow their anti-HIV medication schedules.
It is very important that HIV-positive patients take their anti-HIV medications correctly so they get the best possible benefit from them. Taking the drugs correctly, called "adherence," may keep HIV virus levels in the blood (viral load) low for a longer time. However, anti-HIV medication schedules are often complicated, and many patients have difficulty remembering to take their drugs at the correct time. This study will look at 2 different ways to teach patients about the importance of taking their medications correctly and to remind them when to take their medications.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adherence to antiretroviral (AR) therapy has become increasingly important in the management of HIV infection. Adherence to AR regimens is thought to be a critical factor in maintaining therapeutic drug levels, thus helping ensure viral suppression and minimizing the risk of drug resistance. However, AR regimens are often complex with demanding dosing schedules. Patients often miss doses because they simply forget; other factors such as substance abuse, depression, and low literacy levels also contribute to nonadherence. Adherence is influenced not only by individual behavior but also by the services, the quality of the patient-provider relationship, and the amount of social support offered the patient. There is no currently agreed upon, widely used, and generalizable intervention for improving adherence over the long course of HIV therapy. This study provides a long-term comparative evaluation of two interventions.
Clinical sites, rather than individual patients, are randomized to one of four groups: a medication manager, an electronic medication reminder system, a medication manager plus an electronic medication reminder system, or usual care. Special training sessions are held for the staff of participating units assigned to medication manager and/or electronic medication reminder system interventions. The medication manager is a research staff member who works individually with study patients, addressing the knowledge, motivation, and skills necessary for adherence. The electronic medication reminder system is ALR (A Little Reminder). This is a small, portable alarm that is programmed to sound and flash at the times of the patient's scheduled AR medication doses. Patients enrolling into either the FIRST or MDR-HIV study at clinical sites authorized to carry out this study are offered the option of participating in the adherence intervention to which the clinical site has been randomly assigned. Data collected through the FIRST and the MDR-HIV protocols are used to address the Adherence study objectives. Patients on the FIRST protocol are assessed for time to first plasma HIV-RNA level above 2,000 copies/ml. Also, patients on the FIRST and MDR-HIV studies are assessed for changes in viral load, resistance, CD4 cell counts, adherence, and other factors.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94110
- Community Consortium / UCSF
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San Francisco, California, United States, 94110
- Virginia Cafaro M.D.
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Colorado
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Denver, Colorado, United States, 80204
- Denver CPCRA / Denver Public Hlth
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Denver, Colorado, United States, 80204
- Univ Hosp Infectious Diseases Clinic
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale Univ School of Medicine / AIDS Program
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District of Columbia
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Washington, District of Columbia, United States, 20422
- Washington Reg AIDS Prog / Dept of Infect Dis
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Georgia
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Atlanta, Georgia, United States, 30308
- AIDS Research Consortium of Atlanta
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Illinois
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Chicago, Illinois, United States, 60657
- AIDS Research Alliance - Chicago
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hosp
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Detroit, Michigan, United States, 48201
- Wayne State Univ - WSU/DMC / Univ Hlth Ctr
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New Jersey
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Camden, New Jersey, United States, 08103
- Southern New Jersey AIDS Clinical Trials
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Newark, New Jersey, United States, 07103
- North Jersey Community Research Initiative
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- Partners in Research / New Mexico
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New York
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Bronx, New York, United States, 10453
- Bronx-Lebanon Hosp Ctr
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New York, New York, United States, 10037
- Harlem AIDS Treatment Grp / Harlem Hosp Ctr
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Oregon
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Portland, Oregon, United States, 97210
- The Research and Education Group
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Philadelphia FIGHT
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Texas
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Houston, Texas, United States, 77030
- Univ TX Health Science Ctr
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Virginia
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Richmond, Virginia, United States, 23298
- Richmond AIDS Consortium / Div of Infect Diseases
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients may be eligible for this study if they:
- Are enrolling in a qualifying CPCRA AR therapeutic study. Currently, the FIRST and MDR-HIV studies are the only qualifying protocols.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Are enrolling at a clinic site that is unable to participate in this study for some reason.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Factorial Assignment
Collaborators and Investigators
Investigators
- Study Chair: Sharon Mannheimer
- Study Chair: Edward Morse
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPCRA 062
- 11617 (Registry Identifier: DAIDS ES)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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